- Assess the immunologic response of lymphocytes isolated from lymph nodes draining the vaccination site following a single dose of CD80-transfected MDA-MB-231.

- Assess the development of systemic immunity following multiple injections of CD80-transfected MDA-MB-231.

- Observe for tumor regression.

OUTLINE: This is a dose-escalation study.

Patients receive intradermal vaccinations containing CD80-transfected cells with or without sargramostim (GM-CSF) or with or without BCG. Vaccinations are administered every 2 weeks for 6 weeks and then monthly for 3 months. Patients may receive 1 of 2 different doses of GM-CSF. GM-CSF is administered with the vaccination, then every 12 hours for 7 days. Monthly vaccinations may continue as long as response is shown.

Cohorts of 5 patients each are treated at each dose/combination. Each cohort completes treatment before the next cohort is accrued.

Patients are followed at weeks 4 and 8, then every 2 months for 6 months, then every 3 months for 1 year, and then every 6 months until disease progression.

PROJECTED ACCRUAL: Approximately 35 patients will be accrued for this study within 18 months.

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically proven metastatic breast cancer

- Stage IV disease patients who have either been treated to maximal response or who have had high dose chemotherapy or a marrow ablative regimen (if they meet immunologic criteria and have not received more than 2 chemotherapy regimens for treatment of metastatic disease)

- Patients with advanced stage disease who:

- Received at least 1 standard chemotherapy regimen, but no more than 2, for treatment of metastatic disease

- Refused chemotherapy

- Refused or progressed despite hormonal therapy

- Measurable or evaluable disease

- Positive or negative for HLA-A2

- Must have superficial inguinal or axillary lymph nodes that are free of tumor involvement and are surgically accessible

- No symptomatic or acutely life threatening tumor that is judged likely to require intervention with alternative modalities within 3 months

Name

Location

We are a Cancer Social Network, Resource Directory & Education Hub supporting all those affected by cancer. knowcancer.com is intended to be solely for informational purposes and should not be a substitute for professional medical advice, diagnosis or treatment.